Medical Device Labeling & Regulatory Specialist

MicroAire Surgical Instruments; Charlottesville (VA); On-site; USD 55,000 - 85,000; Full time

Job summary

MicroAire Surgical Instruments LLC is seeking a Labeling Specialist to manage the development, maintenance and controlled implementation of medical device product and packaging labeling aligned with regulatory compliance, new product development and production needs.

The role serves as the primary technical resource for labeling processes and systems, coordinating changes across functions and leading improvements for accuracy, compliance, and efficiency.

Qualifications

• Experience with medical device labeling requirements and regulatory standards.
• Ability to coordinate labeling changes across functions and systems.
• Familiarity with regulatory databases and product registrations.

Responsibilities

• Develops, revises, and verifies product packaging labeling according to approved product information and regulatory requirements, including 21 CFR Part 801, UDI, EU MDR, ISO 15223-1.
• Manages labeling activities with cross-functional teams and drives improvements for accuracy and compliance.
• Supports regulatory database maintenance, product registration, and related regulatory affairs activities as prioritized by the Quality Systems Manager.

Skills

Regulatory labeling

Cross-functional teamwork

Documentation

Attention to detail

Job description

MicroAire Surgical Instruments LLC is seeking a Labeling Specialist to manage the development, maintenance and controlled implementation of medical device product and packaging labeling aligned with regulatory compliance, new product development and production needs.

The role serves as the primary technical resource for labeling processes and systems, coordinating changes across functions and leading improvements for accuracy, compliance, and efficiency.